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The U.S. Supreme Court’s decision in Myriad Genetics sets higher patentability requirements than in Canada

In a recent decision that could significantly affect the biotechnology industry, the United States Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013), held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” However, the Court also held that complementary DNA (cDNA) is patent eligible because it is not a “product of nature.” This decision could call into question the validity of claims of numerous U.S. patents solely directed to isolated genes. It will now likely be difficult to obtain patents protecting newly isolated products of nature in the United States. The decision also raises uncertainty as to what will be required to differentiate “modified” DNA from naturally occurring forms to ensure that such claims are patent eligible. In contrast, claims to genes remain patentable in Canada. Furthermore, claims to other aspects of biotechnological inventions, including cells such as bacterial cell cultures, pluripotent stem cells and plant cells, may also be patentable, assuming the criteria for patentability (namely, novelty, non-obviousness and utility) are met. Thus, the current patent regime in Canada remains favourable for biotechnology companies seeking patent protection for novel genes and related technology.